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Relentless Rise Of Transcatheter Tech: Heart Valve Repair Turns Back On Open Surgery

The global market for products treating heart valve disease is expected to exceed $8bn by 2021, driven largely by the rising number of elderly patients with cardiovascular disease, obesity and growing prevalence of diabetes. This, in turn, is fueling significant innovation in minimally invasive techniques, particularly in the leading area of transcatheter aortic valve replacement (TAVR), but also in transcatheter mitral valve repair (TMVrep) systems, both of which offer patients quicker recovery times, less discomfort and greater safety compared to traditional surgical heart valve repair and replacement. This feature looks more closely at the competitive landscape and dynamics of these two fast-growing market segments, as well as gives insight into what the users – the physicians – think of these technologies.

Cardiovascular Surgical Procedures Market Intelligence

Medicare Agency Solicits Input On ICD Coverage For First Time Since 2005

The US Medicare agency opened a national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators and received input from 35 individuals, organizations, and companies during the initial public comment period. The agency did not specify any particular issues or deficiencies that it wants to address by updating its coverage policy, but CMS has not reconsidered the national coverage policy on ICDs since a major coverage expansion was implemented in 2005.

Medicare Market Access Clinical Trials

Alere Off-Loads Blood Gas Business To Siemens

Alere is selling its Epocal point-of-care blood diagnostics subsidiary to Siemens Healthineers to comply with US antitrust requirements in advance of its pending acquisition by Abbott. Siemens plans to integrate Epocal's epoc blood analysis system with its digital platforms and its existing point-of-care diagnostics.

Commercial Deals M & A

Device Week – July 21, 2017

On this week's Medtech Insight podcast: US Senate passes $2.8bn FDA spending bill; US approvals and clearances strong in first six months of 2017; the global heart-valve repair and replacement devices market is highlighted.

Medical Device FDA Approvals

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Policy & Regulation Explore this Topic

Set Alert for Policy

Unlocking Legalities: Ninth Circuit Allows Wider Range Of False Claim Suits

The Ninth Circuit Court of Appeals allowed False Claims Act allegations against drug manufacturers Gilead Sciences to move forward despite a US Supreme Court ruling last year that raised FCA standards.

Medical Device Legal Issues Unlocking Legalities

How Does UL Acquisition Of Emergo Consultancy Answer Conflict Of Interest Issues?

The recent acquisition of the Emergo medtech consultancy by Underwriters Laboratory has raised a few eyebrows in the sector. Can a notified body and consultancy co-exist without conflicts of interest?

Europe Medical Device Regulation

Fujifilm Recalls ED-530XT Duodenoscope In 'Abundance Of Caution'

Fujifilm Medical Systems issued an urgent medical device correction and removal for its ED-530XT duodenoscope on July 21. The company said it needed to update and replace the scope's forceps elevator mechanism and O-ring seal, distal end cap, and operations manuals in an "abundance of caution" to reduce risk to public health from inadequate reprocessing. FDA said it was working with Fujifilm on the correction.

Recalls Regulation

US FDA's Device-Focused Patient Engagement AdComm Tackles Trial Challenges

FDA's new Patient Engagement Advisory Committee will discuss patient perspectives on device clinical trials at its first scheduled meeting.

Regulation FDA

Warning Letter Roundup & Recap – July 25, 2017

A California-based maker of whirlpool immersion hydrotherapy devices and dry-heat therapy devices garnered the only device-related warning letter posted by FDA this week.

Device Warning Letters Medical Device

Gadolinium Imaging Agents Face EU Suspension

The European Medicines Agency is calling for the suspension of gadolinium imaging agents made by GE Healthcare, Guerbet and Bracco as a precautionary measure. US regulators, in the meantime, are planning to hold a public meeting on the safety of the agents.

Diagnostic Imaging Safety

Turkey Homes In On Imaging Sector To Boost Local Medtech Production

In a bid to increase local products of medical equipment and reduce costs of importing expensive devices, Turkey has introduced financial incentives to attract multinationals to set up manufacturing facilities in the country. One priority area of this initiative will be medical imaging technologies.

Turkey Policy

Class I Recall On Penumbra Revascularization Device

A delivery wire in the stroke treatment device can break or separate during use, putting patients at risk of worsened stroke, death and other adverse events.

Recalls Neurology

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

US FDA Maturity Model Pilot Program Gets October Meeting Date

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

Quality Control Compliance

Compliance Corner: 6 Tips From US FDA To Ensure Robust Software Validation

Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.

Quality Control Compliance

Aerospace Heat Treating Standard Recognized By US FDA, Giving Nudge To MedAccred Supplier-Control Program

The agency's Center for Devices and Radiological Health has formally recognized pyrometry standard AMS 2750 for heat treating. Originally drafted by SAE International in 1980 for the aerospace industry, the standard is the foundation of heat treating audit criteria for the burgeoning medical device supply-chain oversight program MedAccred.

Quality Control Medical Device

Commercial Explore this Topic

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Insulet, Ypsomed Split Up And Go Head-To-Head In Insulin Pump Market

Insulin pump commercial partners Insulet and Ypsomed will be parting ways after some eight years in an exclusive distribution alliance. The companies failed to reach an agreement to renew the distributor agreement, which will end June 2018, following differences on price. Ypsomed announced it will introduce its own tubeless insulin pump in the mid-term.

Diabetic Care Companies Commercial

Latest From Commercial

Estrampes Appointed To Helm Of GE Healthcare EU

GE Healthcare has appointed Catherine Estrampes as CEO of its European operations, replacing Jean-Michel Malbrancq who is leaving to pursue opportunities outside of GE after 35 years with the company.

Companies Appointments

Apollo Endosurgery Seeks To Raise $31m In Share Sale

Anti-obesity device company Apollo Endosurgery is looking to net around $31m through a sale of 5.7 million shares. The Austin, Texas-based company has seen slow sales in the last couple of years and is planning to use the funds to boost adoption of its endo-bariatric products, which includes the Orbera intragastric balloon and the Lap-Band gastric band which it inherited through acquiring Allergan’s obesity intervention division in 2013.

Financing Deals

numares Targets 2018 For Metabolomic Bladder Cancer Test

German diagnostics firm numares AG is targeting 2018 for a launch of a bladder cancer test based on its metabolomic biomarker network technology. The company obtained promising results from a retrospective study indicating that evaluation of metabolomic biomarker networks can be used as a diagnostic for bladder cancer.

In Vitro Diagnostics Cancer

'Profitable, High-Growth' CellRight Bulks Up Tissue Regenix's Ortho Biz

In acquiring CellRight Technologies, a young but already profitable US company specializing in regenerative bone technologies, UK regenerative medicine firm Tissue Regenix will significantly bulk up its portfolio and accelerate its global commercial growth plans.

M & A Regenerative Medicine

Alere Unloads Its Triage Assets To Quidel

The deal, subject to the completion of Abbott's planned acquisition of Alere, includes the Triage MeterPro cardiovascular and toxicology businesses, as well as the Triage BNP business. These additions will diversify Quidel's portfolio of rapid diagnostic products for critical care settings and give it a stronger presence in the point-of-care market.

In Vitro Diagnostics M & A

Judge Rules For Enhanced Damages In Zimmer-Stryker Patent Spat

The case had gone to the US Supreme Court due to a dispute over the standards for enhanced damages. Zimmer, which was ordered to pay almost $250m in costs and penalties, expects to appeal the verdict.

Legal Issues Intellectual Property

Clinical R&D Explore this Topic

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Agendia Touts ASCO Guideline's Endorsement Of MammaPrint Breast Cancer Test

Results of the MINDACT trial, which show that Agendia BV's MammaPrint 70-gene lab test can identify about half of the early-stage breast cancer patients who do not need chemotherapy, has led the American Society of Clinical Oncology to specifically recommend the test in its guidelines.

Clinical Trials Market Access Cancer

Latest From Research & Development

Humabs Biomed Zika Assay Pinpoints Virus From Other Flavivirus Infections

A novel antibody-based Zika virus assay developed by Humabs Biomed, the NS1 Blockade-of-Binding (BOB) ELISA, can accurately distinguish Zika virus from other viruses, and differentiate it from other flavivirus infections within three hours, according to a recent article in the Proceedings of the National Academy of Sciences. Work to commercially develop the test is just beginning, so the company has not yet submitted it to FDA.

In Vitro Diagnostics United States

Digital Update: UK Peer Pressure, US Tech Advances And EU Common Goals Put eHealth To Top Of Agenda

Funding is taking a long time to come through for the UK NHS's digital health care transformation, but as the national provider's head of technology strategy, Dr Paul Rice says, "We can't afford to remain non-digital." Estonia, currently holding the presidency of the EU Council of Ministers, gets that too, while US digital champions like Kaiser Permanente and disruptive technology inventors like Mindstrong Health are forcing the pace.

Digital Health Medical Device

First MRI Scanner Designed For NICU Babies Gets US Clearance

Israel's Aspect Imaging has scored the first 510(k) for an MRI machine specifically designed to scan infants in neonatal intensive care units where radiowaves from traditional MRIs could risk interfering with other hospital equipment.

Pediatrics Approvals

OUS Approvals: Neurostim And Cardiovascular Lead June Surge

Approvals of neurostimulation and cardiology devices dominated the list of non-US medtech approvals in June. According to Medtech Insight's Approvals Tracker, there were 36 medtech approvals outside the US last total that month, including 28 CE marks in Europe, plus approvals from China, Canada, Australia/New Zealand and Brazil.

Approvals Innovation

US Approvals Analysis: FDA Delivers Strong Half-Year Volumes

US FDA Device-approval volumes were strong during the first half of 2017 for all review pathways. Medtronic and Siemens have so far captured the most 510(k) clearances, with Cook close behind. That and more from Medtech Insight's Approvals Tracker.

Approvals Innovation

Myriad Innovations At MedFIT, But Graphene Wound Dressing And Back Pain Relief Exoskeleton Get The Votes

The first edition of the European medtech partnering conference MedFIT provided a showcase for early-stage innovations emerging from the R&D labs of start-ups and tech incubators, all poised to be taken to the next level of clinical evaluation or even commercialization. Medtech Insight attended the event's Start-Up Slam where eight medtech innovations vied to win over the jury of potential investors and industry experts, as well as the audience.

Innovation StartUps and SMEs